Trial document




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  DRKS00006208

Trial Description

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Title

Epidemiological cross-sectional study on the impact of malocclusion and habits on oral health and quality of life

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Orthodontics is a specialty of dentistry and deals with the treatment of misalignments off teeth and jaws. Until now only limited evidence-based information is available regarding the impact of malocclusion and dysgnathia and their treatment on oral health and associated quality of life of the patient. It is supposed that crowding of teeth leads to increased prevalence of caries, periodontal pockets, periodontitis and recessions as well as an increased risk of dental infractions due to retentive areas for debris or overexertion of misaligned teeth in functional movements. Caries and periodontitis have an extremely high prevlance of up to 90% in school children are are defined as "most important global oral health burden". They in the long term lead to limited masticatory function and phonetics as well as dental pain and a loss of teeth. Orthodontic corrections could therefore have an important prophylactic function for the onset and progression of these diseases.

Up to no no clear evidence-based statement about a possible correlation of malocclusions/habits and different oral illnesses such as caries, gingivitis/periodontitis, temporomandibular disorders as well as oral health related quality of life. Previous investigations were only limited to juvenile patients, had limited case numbers and showed contradictory results. If correlations can be shown, this is of great importance for patients, since the epidemiological, evidence-based data would indicate a re-evaluation and scientific confirmation or extension of the indications for orthodontic therapy for the correction of malocclusions and habits.
For this reason possible correlations between malocclusions/habits and oral illnesses as well as associated quality of life are to be investigated in an epidemiological multicenter trial.

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Organizational Data

  •   DRKS00006208
  •   2017/02/08
  •   [---]*
  •   yes
  •   Approved
  •   17-419-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   U1111-1192-6884 
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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
  •   K07.0 -  Major anomalies of jaw size
  •   K07.1 -  Anomalies of jaw-cranial base relationship
  •   K07.2 -  Anomalies of dental arch relationship
  •   K07.3 -  Anomalies of tooth position
  •   K07.4 -  Malocclusion, unspecified
  •   K07.5 -  Dentofacial functional abnormalities
  •   K07.6 -  Temporomandibular joint disorders
  •   K07.8 -  Other dentofacial anomalies
  •   K05.0 -  Acute gingivitis
  •   K05.1 -  Chronic gingivitis
  •   K05.2 -  Acute periodontitis
  •   K05.3 -  Chronic periodontitis
  •   K05.4 -  Periodontosis
  •   K03.0 -  Excessive attrition of teeth
  •   K03.1 -  Abrasion of teeth
  •   K03.2 -  Erosion of teeth
  •   K03.6 -  Deposits [accretions] on teeth
  •   K03.7 -  Posteruptive colour changes of dental hard tissues
  •   K03.8 -  Other specified diseases of hard tissues of teeth
  •   K13.1 -  Cheek and lip biting
  •   K13.2 -  Leukoplakia and other disturbances of oral epithelium, including tongue
  •   K13.3 -  Hairy leukoplakia
  •   K13.4 -  Granuloma and granuloma-like lesions of oral mucosa
  •   K13.5 -  Oral submucous fibrosis
  •   K13.6 -  Irritative hyperplasia of oral mucosa
  •   K13.7 -  Other and unspecified lesions of oral mucosa
  •   F99 -  Mental disorder, not otherwise specified
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Interventions/Observational Groups

  •   14 clinical-oral inspections and 9 questionnaires concerning state of malocclusion, habits, oral health and quality of life;

    The participants receive a detailed information sheet, the consent form and the questionnaires and are informed orally and thoroughly about the study by the respective investigator. Participation is voluntary and there is always the possibility to ask questions.

    After informed consent the questionnaires are completed by the study participant. The completed questionnaires are then briefly screened by the investigator and missing/unclear information and answers discussed and completed with the participant. Then the clinical-oral investigation follows.

    1.Demographic data and oral health.
    Literature: WHO Oral Health Assessment Form for Adults und OHQA Oral Health Questionnaire for Adults (WHO)

    2.Oral Health: SOHSI Subjective Oral Health Status Indicators
    Literature: Locker and Miller, 1994

    3.Quality of Life: OHIP-G-14 as German version of the OHIP-14 questionnaire on oral-health-related quality of life (OHRQOL)
    Literature: John et al. 2006

    4.Quality of Life: RSS Rosenberg-Self-Esteem Scale (revised)
    Literature: Collani und Herzberg 2003

    5.Quality of Life: IOTN-AC
    Literature: Daniels and Richmond 2000

    6.Quality of Life: OASIS (Oral Aesthetic Subjective Impact Scale)
    Literature: Mandall et al. 1999

    7.Okklusion: PoOS (Perception of Occlusion Scale)
    Literature: Espeland and Stenvik 1991

    8.CMD: modified anamnestic index according to Helkimo
    Literature: Conti et al. 2003

    9.Quality of Life: PIDAQ (psychosocial impact of dental aesthetics questionnaire)
    Literature: Klages et al. 2006

    All investigations take place in a dentist's room on a dentist's chair in slightly reclined position at natural illumination without direct sunlight or alternatively at constant artifical illumination. A dental probe and mirror as well as a WHO-probe and PA millimeter probe are used.

    1.Caries: DMFT-index (WHO)
    2.Plaque/Oral Hygiene: PI (Plaque-Index) according to Silness/Löe
    3.Gingivitis/Oral Hygiene: GI (Gingiva-Index) according to Löe/Silness
    4.Periodontal Health: CPITN-Index (WHO, Aimano et al. 1982)
    5.Periodontal Health: Gingival Recession Index (Miller 1985)
    6.Dental trauma (WHO)
    7.Abrasions/Erosions (WHO)
    8.Soft Tissue Diseases (WHO)
    9.Enamel Fluorosis (WHO)
    10.Dental prosthesis (WHO)
    11.Habits and oral dysfunctions
    12.Malocclusion – anterior crowding: Irregularity Index according to Little (1975)
    13.Malocclusion: DAI (Dental Aesthetic Index) according to WHO criteria (Cons et al. 1986, Jenny and Cons 1996)
    14.Malocclusion: IOTN-DHC (Index of Orthodontic Treatment Need – Dental Health Component) according to Brook and Shaw 1989
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

14 clinical-oral inspections and 9 questionnaires:

a)Do malocclusions and habits, TMD/occlusion impact on quality of life?
b)Does oral health impact on quality of life?
c)Do correlations exist between malocclusions/habits and oral health/TMD/occlusion?

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Secondary Outcome

14 clinical-oral inspections and 9 questionnaires:

a)Do differences in gender and age and background exist regarding the prevalence of malocclusion, habits, TMD/occlusion, oral health and quality of life?
b)Do differences exist regarding the sites of recruitment?
c)Does subjective oral health status concur with the actual oral health status?
d)Do subjective malocclusion/need for orthodontic treatment correlate with actual malocclusion/need for orthodontic treatment?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • other 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/03/01
  •   818
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

>18 years of age;

no syndromes/dentofacial anomalies;

no present
•orthodontic treatment
•orthodontic retention;

no present or previous
•orthognathic surgery
•periodontal surgery;

healthy
(no serious or chronical ailments or metabolical disorders and regular medication within the previous 3 months)

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Exclusion Criteria

<18 years of age;

syndromes;dentofacial anomalies

present
•orthodontic treatment
•orthodontic retention;

present or previous
•orthognathic surgery
•periodontal surgery;

patient not healthy
(serious or chronical ailments or metabolical disorders or regular medication within the previous 3 months)

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Addresses

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    • Universitätsklinikum Regensburg,Poliklinik für Kieferorthopädie
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Mr.  PD Dr. Dr.  Christian  Kirschneck 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Poliklinik für Kieferorthopädie,Universitätsklinikum Regensburg
    • Mr.  PD Dr. Dr.  Christian  Kirschneck 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Regensburg
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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